EP3705118A4 - Zusammensetzung einer oralen festen darreichungsform mit verbesserter auflösung und verfahren zu ihrer herstellung - Google Patents
Zusammensetzung einer oralen festen darreichungsform mit verbesserter auflösung und verfahren zu ihrer herstellung Download PDFInfo
- Publication number
- EP3705118A4 EP3705118A4 EP18872612.9A EP18872612A EP3705118A4 EP 3705118 A4 EP3705118 A4 EP 3705118A4 EP 18872612 A EP18872612 A EP 18872612A EP 3705118 A4 EP3705118 A4 EP 3705118A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- preparation
- dosage form
- solid dosage
- method therefor
- oral solid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000203 mixture Substances 0.000 title 1
- 239000008184 oral solid dosage form Substances 0.000 title 1
- 238000002360 preparation method Methods 0.000 title 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
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- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4025—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil not condensed and containing further heterocyclic rings, e.g. cromakalim
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- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
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- A61K31/4164—1,3-Diazoles
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- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
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- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
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- A61K31/501—Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
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- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Inorganic Chemistry (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Emergency Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR20170144139 | 2017-10-31 | ||
PCT/KR2018/013034 WO2019088669A1 (ko) | 2017-10-31 | 2018-10-30 | 붕해가 개선된 경구용 고형 제제 조성물 및 이의 제조 방법 |
Publications (3)
Publication Number | Publication Date |
---|---|
EP3705118A1 EP3705118A1 (de) | 2020-09-09 |
EP3705118A4 true EP3705118A4 (de) | 2021-08-18 |
EP3705118B1 EP3705118B1 (de) | 2024-02-14 |
Family
ID=66332189
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18872612.9A Active EP3705118B1 (de) | 2017-10-31 | 2018-10-30 | Zusammensetzung einer oralen festen darreichungsform mit verbesserter auflösung und verfahren zu ihrer herstellung |
Country Status (5)
Country | Link |
---|---|
US (1) | US11980610B2 (de) |
EP (1) | EP3705118B1 (de) |
JP (2) | JP7458317B2 (de) |
KR (3) | KR102333609B1 (de) |
WO (1) | WO2019088669A1 (de) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11980610B2 (en) * | 2017-10-31 | 2024-05-14 | Samyang Holdings Corporation | Oral solid dosage form composition having improved disintegration and preparation method therefor |
WO2021155254A1 (en) | 2020-01-31 | 2021-08-05 | Nanocopoeia, Llc | Amorphous nilotinib microparticles and uses thereof |
IL297776A (en) | 2020-04-30 | 2022-12-01 | Nanocopoeia Llc | Orally disintegrating tablets containing an amorphous solid dispersion of nalotinib |
IT202000027678A1 (it) * | 2020-11-18 | 2022-05-18 | Indena Spa | Dispersioni solide amorfe di cabozantinib-(s)-malato e processi per la loro preparazione |
WO2022115464A1 (en) * | 2020-11-25 | 2022-06-02 | Nanocopoeia, Llc | Amorphous cabozantinib particles and uses thereof |
AU2021391823A1 (en) | 2020-12-03 | 2023-06-29 | Battelle Memorial Institute | Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery |
CA3155855A1 (en) * | 2020-12-07 | 2022-06-07 | Tianjin Creatron Biotechnology Co., Ltd. | Sorafenib pharmaceutical composition with high bioavailability and use thereof |
WO2022177983A1 (en) * | 2021-02-19 | 2022-08-25 | Slayback Pharma Llc | Pharmaceutical compositions of cabozantinib |
JP2024516108A (ja) | 2021-04-07 | 2024-04-12 | バテル・メモリアル・インスティテュート | 非ウイルス性担体を同定および使用するための迅速な設計、構築、試験、および学習技術 |
CN113069418A (zh) * | 2021-04-21 | 2021-07-06 | 海南通用三洋药业有限公司 | 一种阿莫西林颗粒的制备方法 |
CN114306271B (zh) * | 2021-11-24 | 2023-04-07 | 石药集团中奇制药技术(石家庄)有限公司 | 一种仑伐替尼组合物 |
Citations (3)
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WO2004006904A1 (en) * | 2002-07-16 | 2004-01-22 | Seoul Pharm. Co., Ltd. | Oral controlled-release dosage forms containing acetaminophen |
KR20090131584A (ko) * | 2008-06-18 | 2009-12-29 | 한국콜마 주식회사 | 매스틱을 포함하는 발포성 속붕해정 |
CN102319251A (zh) * | 2011-07-19 | 2012-01-18 | 淄博职业学院 | 阿司匹林双嘧达莫胃内漂浮胶囊及其制备方法 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TW486370B (en) * | 1996-12-25 | 2002-05-11 | Yamanouchi Pharma Co Ltd | Rapidly disintegrable pharmaceutical composition |
WO2002069932A1 (fr) * | 2001-03-05 | 2002-09-12 | Nippon Shinyaku Co., Ltd. | Compositions moussantes |
CN101299993A (zh) * | 2005-11-04 | 2008-11-05 | 伊士曼化工公司 | 用于给药难溶的药学活性剂的羧烷基纤维素酯 |
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KR20130068291A (ko) * | 2011-12-15 | 2013-06-26 | 주식회사 삼양바이오팜 | 이매티닙 유리염기를 포함하는 고체분산체 및 그의 제조방법 |
US11980610B2 (en) * | 2017-10-31 | 2024-05-14 | Samyang Holdings Corporation | Oral solid dosage form composition having improved disintegration and preparation method therefor |
-
2018
- 2018-10-30 US US16/760,302 patent/US11980610B2/en active Active
- 2018-10-30 WO PCT/KR2018/013034 patent/WO2019088669A1/ko unknown
- 2018-10-30 EP EP18872612.9A patent/EP3705118B1/de active Active
- 2018-10-30 KR KR1020180130400A patent/KR102333609B1/ko active IP Right Grant
- 2018-10-30 JP JP2020523987A patent/JP7458317B2/ja active Active
-
2021
- 2021-11-26 KR KR1020210165553A patent/KR102546742B1/ko active IP Right Grant
-
2022
- 2022-08-04 JP JP2022124986A patent/JP2022153652A/ja active Pending
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2023
- 2023-06-19 KR KR1020230078247A patent/KR20230093401A/ko not_active Application Discontinuation
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Also Published As
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JP2022153652A (ja) | 2022-10-12 |
JP2021501166A (ja) | 2021-01-14 |
KR102546742B1 (ko) | 2023-06-23 |
EP3705118B1 (de) | 2024-02-14 |
US20200261426A1 (en) | 2020-08-20 |
US11980610B2 (en) | 2024-05-14 |
JP7458317B2 (ja) | 2024-03-29 |
KR20210149002A (ko) | 2021-12-08 |
KR20190049543A (ko) | 2019-05-09 |
KR20230093401A (ko) | 2023-06-27 |
EP3705118A1 (de) | 2020-09-09 |
KR102333609B1 (ko) | 2021-12-01 |
WO2019088669A1 (ko) | 2019-05-09 |
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